ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Evaluation of Insect Repellent and Insecticide Treated Nets in Lao PDR

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00938379
Recruitment Status : Unknown
Verified July 2009 by London School of Hygiene and Tropical Medicine.
Recruitment status was:  Recruiting
First Posted : July 13, 2009
Last Update Posted : July 14, 2009
Sponsor:
Collaborator:
Population Services International
Information provided by:
London School of Hygiene and Tropical Medicine

Brief Summary:

Rural communities involved in agriculture are often at highest risk of insect-borne diseases in Southeast (SE) Asia.

Skin-applied insect repellents may prove a useful means of reducing mosquito-borne diseases for those people working outdoors in high risk areas.

This trial is evaluating the use of insect repellent (20% diethyltoluamide) to reduce incidence of malaria, Japanese Encephalitis and Dengue. The investigators will recruit up to 1000 households from 100 villages in rural Laos. In each house the investigators shall recruit up to 5 individuals. Half of households will be randomised to repellent, half to a placebo. All individuals will be provided with insecticide treated bed nets for use at night. All household occupants will be followed for 7 months to record malaria cases by Rapid Diagnostic Test every month. Blood spots will be collected at start and end of study to measure Japanese Encephalitis and Dengue. All positive cases will be promptly treated. Outcome will be reduction in number of malaria cases (primary outcome) and Dengue/Japanese Encephalitis (secondary outcomes).


Condition or disease Intervention/treatment Phase
Malaria Dengue Japanese Encephalitis Drug: 20% deet insect repellent Drug: placebo control Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical Evaluation of Insect Repellent and Insecticide Treated Nets Against Malaria, JE & Dengue in Rural Communities in Lao PDR
Study Start Date : July 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : June 2011


Arm Intervention/treatment
Experimental: 20% deet insect repellent
experimental intervention
Drug: 20% deet insect repellent
skin-applied repellent lotion
Placebo Comparator: lotion without repellent active Drug: placebo control
Identical base formulation of lotion but without any deet active



Primary Outcome Measures :
  1. reduction in malaria incidence [ Time Frame: monthly over 7 months ]

Secondary Outcome Measures :
  1. Reduction in Japanese Encephalitis and / or Dengue infections [ Time Frame: After 7 months intervention ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • working in agriculture
  • available for monthly follow-up

Exclusion Criteria:

  • allergy to repellent
  • pregnant / breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938379


Contacts
Contact: Vanessa Chen-Hussey, MSc vanessa.chen-hussey@lshtm.ac.uk

Locations
Lao People's Democratic Republic
Rural villages in Attepu and Sekong Provinces, Laos PDR Recruiting
Pakse, Attepu, Lao People's Democratic Republic
Contact: Vanessa Chen-Hussey, MSc    856 (0)21 353 408 ext 116    vanessa.chen-hussey@lshtm.ac.uk   
Principal Investigator: Vanessa Chen-Hussey, MSc         
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Population Services International
Investigators
Principal Investigator: Nigel Hill, PhD LSHTM

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Nigel Hill, Head of Unit, Disease Control & Vector Biology
ClinicalTrials.gov Identifier: NCT00938379     History of Changes
Other Study ID Numbers: NHLAO1
First Posted: July 13, 2009    Key Record Dates
Last Update Posted: July 14, 2009
Last Verified: July 2009

Keywords provided by London School of Hygiene and Tropical Medicine:
mosquito
repellent
vector control
malaria

Additional relevant MeSH terms:
Dengue
Malaria
Encephalitis
Encephalitis, Japanese
Protozoan Infections
Parasitic Diseases
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Encephalitis, Viral
Central Nervous System Viral Diseases
Infectious Encephalitis
Central Nervous System Infections
Insect Repellents
Protective Agents
Physiological Effects of Drugs